Features & Benefits:
- Maximum ASTM level 3 barrier protection for use in surgical settings.
- Engineered with proprietary, high-efficiency filter media to improve airborne particulate capture and lower resistance to breathing.
- Mask filter media captures a minimum of 98% of particles 0.3 microns and larger.
- Unique, low-profile and contoured design is optimized to accommodate eyewear with exhaled air directed away from the nose to reduce fogging.
- Maximum comfort for long-term wear environments:
- Comfortflex™ earloops
- Adjustable nosepiece
- Soft inner fabric
- Lightweight construction
- Ergonomic design fits most face sizes.
Approvals & Standards:
- ASTM F2100-19 Level 3 Barrier Protection
- Satisfies FDA Emergency Use Authorization for Use by Healthcare Professionals.
- Surgical masks are not intended to provide protection against pathogenic biological airborne particulates and are not recommended for use in aerosol generating procedures and any clinical conditions where there is significant risk of infection through inhalation exposure.
- Wearer must read fitting instructions and use limitations before use.
- Maximum performance requires that masks be properly fitted to insure a proper seal around the user’s face.
- For consumer use only. Not for occupational use.
- Disposable, one time use only.
- Not NIOSH certified. This product has not been FDA cleared or approved. This product is not intended to replace the need for FDA-cleared surgical masks or FDA-cleared or authorized respirators.
- The product has been authorized by FDA under an EUA for use in healthcare settings by HCP as PPE to provide a physical barrier to fluids and particulate materials to prevent HCP exposure to respiratory droplets and large particles during surgical mask shortages resulting from the COVID-19 pandemic.
- This product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
Office Phone: 740-983-2552
PO Box 257
Ashville, OH 43103